Lung Cancer Clinical Trial
Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Summary
The purpose of this study is to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody, with the anti-PD-(L)1 antibody administered in combination with or sequentially before or after the platinum-based chemotherapy.
Eligibility Criteria
Key Inclusion Criteria:
Metastatic or unresectable locally advanced histologicallyor cytologically confirmed Non-Small Cell Lung Cancer (NCSLC), not amenable to treatment with curative intent
Able to provide archival/fresh tumor tissues for biomarker analysis to assess PD-L1 expression and other biomarkers.
No known Epidermal Growth Factor Receptor (EGFR) or B-Raf proto-oncogene (BRAF) sensitizing mutation, or anaplastic lymphoma kinase (ALK) rearrangement or ROS proto oncogene 1 (ROS1) rearrangement
Radiographic progression per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 on or after anti-PD-(L)1 containing therapy for locally advanced and unresectable or metastatic NSCLC.
No prior anticancer therapy having the same mechanism of action as sitravatinib (eg, tyrosine kinase inhibitor with a similar target profile or Vascular endothelial growth factor (VEGF)- or VEGFR inhibitor)
At least 1 measurable lesion as defined based on RECIST v1.1 by investigator
Key Exclusion Criteria:
Has received docetaxel as monotherapy or in combination with other therapies.
Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (> 50 mL/day)
Participants with tumor shown by imaging to be located around important vascular structures or if the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding.
Active leptomeningeal disease for metastatic NSCLC, or uncontrolled or untreated brain metastasis.
Active autoimmune diseases or history of autoimmune diseases that may relapse.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 58 Locations for this study
Blacktown New South Wales, 2148, Australia
Campbelltown New South Wales, 2560, Australia
Kogarah New South Wales, 2217, Australia
Tweed Heads New South Wales, 2485, Australia
Benowa Queensland, 4217, Australia
Cairns Queensland, 4870, Australia
Adelaide South Australia, 5000, Australia
Clayton Victoria, 3168, Australia
Epping Victoria, 3076, Australia
Fitzroy Victoria, 3065, Australia
St Albans Victoria, 3021, Australia
Hefei Anhui, 23008, China
Beijing Beijing, 10014, China
Beijing Beijing, 10073, China
Chongqing Chongqing, 40003, China
Chongqing Chongqing, 40004, China
Fuzhou Fujian, 35000, China
Fuzhou Fujian, 35001, China
Xiamen Fujian, 36100, China
Lanzhou Gansu, 73000, China
Guangzhou Guangdong, 51003, China
Guangzhou Guangdong, 51008, China
Guangzhou Guangdong, 51051, China
Shantou Guangdong, 51503, China
Shenzhen Guangdong, 51811, China
Nanning Guangxi, 53002, China
Nanning Guangxi, 53002, China
Harbin Heilongjiang, 15000, China
Zhengzhou Henan, 45000, China
Zhengzhou Henan, 45005, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43003, China
Wuhan Hubei, 43007, China
Changsha Hunan, 41001, China
Chenzhou Hunan, 42300, China
Hengyang Hunan, 43040, China
Changzhou Jiangsu, 21300, China
Nanjing Jiangsu, 21000, China
Nanjing Jiangsu, 21000, China
Suzhou Jiangsu, 21500, China
Suzhou Jiangsu, 21500, China
Xuzhou Jiangsu, 22100, China
Nanchang Jiangxi, 33000, China
Nanchang Jiangxi, 33000, China
Changchun Jilin, 13002, China
Dalian Liaoning, 11601, China
Shenyang Liaoning, 11004, China
Yinchuan Ningxia, 75000, China
Jinan Shandong, 25001, China
Jinan Shandong, 25011, China
Qingdao Shandong, 26600, China
Shanghai Shanghai, 20002, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20004, China
Chengdu Sichuan, 61004, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30005, China
Tianjin Tianjin, 30006, China
Urumqi Xinjiang, 83000, China
Kunming Yunnan, 65010, China
Hangzhou Zhejiang, 31001, China
Hangzhou Zhejiang, 31002, China
Taizhou Zhejiang, 31700, China
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